Chronic Myeloid Leukemia

also called: Chronic Myelogeneous LeukemiaA chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

Inclusion criteria

Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.

Chronic phase

The earliest phase of CML development.

Adverse event

An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.

Also called: AE

Indication

In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.

Bosutinib

Bosutinib (development name SKI-606, trade name Bosulif), a second generation tyrosine kinase inhibitor.

Also called Bosulif|SKI-606|SKI606

BCR-ABL

The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22

Chronic

Long-lasting, slowly developping

CML

Chronic Myeloid Leukemia, also called Chronic Myelogenous LeukemiaA chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

CHR

Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.

Scientific title

Indication and most important inclusion criteria

Male or female patients 60 years of age or older with a molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase and prior first-line treatment with any other tyrosine kinase inhibitor.Patients can be considered for inclusion in the study if they are intolerant to prior treatment, based on investigator and patient assessment, or have not responded to prior treatment (assessed according to any one of the ELN 2013 criteria).

Short description of intervention

The purpose of this study is to evaluate the tyrosine kinase inhibitor (TKI) bosutinib in elderly patients who did not obtain any benefit with other drugs before.

The median age of newly diagnosed CML patients is about 56 years, and at least 40% of all newly diagnosed patients are over 60 years old. Particularly for these elderly patients, the choice of TKI must take into account the safety and tolerability profile of the drug. This study tests the efficacy, safety and tolerability of bosutinib in second-line treatment, beginning with a low dose (200 mg once daily) and adjusting subsequent doses (up to 400 mg once daily) based on molecular response and on adverse events.

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Italy

Ancona S. Rupoli

Bari G. Specchia

BolognaS. Orsola-Malpighi University HospitalG. Rosti

Cagliari"A. Businco"E. Usala

CataniaF. Stagno

Cuneo D. Rapezzi

FerraraF. Cavazzini

GenovaIRCCS San MartinoM. Gobbi

MeldolaIRSTA. Lucchesi

MessinaPoliclinico G. MartinoC. Musolino

MilanoIst. Nazionale TumoriF. Spina

MilanoOsp. Maggiore PoliclinicoA.Iurlo

MilanoOspedale San RaffaeleF. Ciceri

NapoliUniv. Studi Napoli "Federico II"F. Pane

NovaraM. Lunghi

OrbassanoC. Rege Cambrin

ParmaM. Crugnola

PiacenzaD. Vallisa

RavennaM. Salvucci

Reggio EmiliaI. Capodanno

RiminiA. L. Molinari

Roma GemelliF. Sorà

RomaOspedale Sant'EugenioE. Abruzzese

RomaSan Giovanni AddolorataM. Cedrone

Roma S.Camillo Forlanini Hospital Dr. S.Mancini

San Giovanni RotondoN. Cascavilla

SienaM. Bocchia

TorinoCittà della salute e della scienzaD. Ferrero

VeronaM. Bonifacio

Chronic Myeloid Leukemia

also called: Chronic Myelogeneous LeukemiaA chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

Inclusion criteria

Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.

Chronic phase

The earliest phase of CML development.

Adverse event

An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.

Also called: AE

Indication

In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.

Bosutinib

Bosutinib (development name SKI-606, trade name Bosulif), a second generation tyrosine kinase inhibitor.

Also called Bosulif|SKI-606|SKI606

BCR-ABL

The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22

Chronic

Long-lasting, slowly developping

CML

Chronic Myeloid Leukemia, also called Chronic Myelogenous LeukemiaA chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

CHR

Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.

CAM

Complementary and Alternative Medicine

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